Prytime Medical Devices, Inc.: PRYTIME MEDICAL REBOA Catheter Introducer Kit, REF: KT1835C, Contents: Needle, 18 GA x 7 CM ECHOGENIC, STERILE, 1 EA, SYRINGE, 30CC, STERILE 1 EA, INTRODUCER SHEATH KIT, 7 FR W/.035 SHORT GUIDEWIRE, STERILE 1 EA., PREFILLED, STERILE FIELD SALINE SYRINGE, 10 ML, 4 EA, CLAMP, 5 FR, STERILE, 1 EA, SCALPEL, #11SS, STERILE, 1 EA, SUTURE, NYLON, 18", 2-0, REVERSE CUTTING, STERILE 1 EA, THREE QUARTER DRAPE, STERILE 1 EA, INSERT, SALINE 1 EA, INSERT, CLAMP 1 EA UDI: (01) 0 0863092 00010 1

Recall number

Z-0959-2021

Recalling firm

Prytime Medical Devices, Inc.

Product

PRYTIME MEDICAL REBOA Catheter Introducer Kit, REF: KT1835C, Contents: Needle, 18 GA x 7 CM ECHOGENIC, STERILE, 1 EA, SYRINGE, 30CC, STERILE 1 EA, INTRODUCER SHEATH KIT, 7 FR W/.035 SHORT GUIDEWIRE, STERILE 1 EA., PREFILLED, STERILE FIELD SALINE SYRINGE, 10 ML, 4 EA, CLAMP, 5 FR, STERILE, 1 EA, SCALPEL, #11SS, STERILE, 1 EA, SUTURE, NYLON, 18", 2-0, REVERSE CUTTING, STERILE 1 EA, THREE QUARTER DRAPE, STERILE 1 EA, INSERT, SALINE 1 EA, INSERT, CLAMP 1 EA UDI: (01) 0 0863092 00010 1

Status

Terminated

Initiated

2020-12-14

Posted

not on file

Terminated

2022-09-28

Reason

There is a potential that a catheter convenience set contains a 21G access needle instead of the correct 18G needle. If the 21G needle is used to gain vascular access then the guidewire included in the kit will not pass through the access needle to facilitate insertion of an introducer sheath and could therefore cause procedure delay or injury.

Root cause

Mixed-up of materials/components

Action

On 12/14/2020, Prytime Medical sent an "Urgent Medical Device Recall Notification" to affected consignees via FedEx. In addition to informing consignees about the recall, the firm asked consignees to take the following actions: 1) Please immediately review your inventory for the recalled lot specified in this notification. Quarantine and do NOT use this lot. 2) If you have an urgent need for this kit, and dont have an alternative lot available then please ensure that you have a backup 18 gauge access needle readily available at the point of use. Do not use the 21G access needle in the kit. 3) Immediately complete and return the attached Customer Response Form to the contact on the form. a. Please specify the number of affected kits in your possession. b. Prytime will promptly contact you to arrange return and replacement shortly after receiving the completed form. 4) Share this recall notification with any users of the product within your facilities, or anyone else you may have sent the product to, in order to ensure they are also aware of this recall. 5) Report any adverse health consequences experienced with the use of this product to Prytime using the attached form, or by email at recall@prytimemedical.com, or by phone at (210) 340-0116. If you have any questions or discover any additional REBOA Convenience Set KT1835C Lot MFG3590 at your facility please contact the Recall Coordinator by phone at (210) 340-0116, or by email at recall@prytimemedical.com.

Quantity

not on file

Distribution

US Nationwide distribution including in the states of NJ, NY, CA, TX, MI, MO, CO, MI, VA, DE, TN, MO, MT, AZ, FL, WI, SC, WA, TX, CT, IN, PA, ME, WI, MA, GA, OH, AR, UT, NY OUS: None

Lot, serial or model codes

Lot # MFG 3590

510(k) numbers

not on file

PMA numbers

not on file

Product code

OFC

Firm FEI

3012279212

Firm city

Boerne

Firm state

TX

Firm country

not on file

Cite as

FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28

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